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Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
This study is ongoing, but not recruiting participants.
Study NCT00006081   Information provided by National Cancer Institute (NCI)
First Received: August 3, 2000   Last Updated: July 23, 2008   History of Changes

August 3, 2000
July 23, 2008
June 2000
 
 
 
Complete list of historical versions of study NCT00006081 on ClinicalTrials.gov Archive Site
 
 
 
Combination Chemotherapy in Treating Patients With Unresectable Locally Advanced or Metastatic Stomach Cancer
A Phase II Study of Bryostatin-1 (NSC 339555) Plus Paclitaxel in Patients With Metastatic or Unresectable Locally Advanced Adenocarcinoma of the Stomach or Gastroesophageal Junction

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of combining bryostatin 1 and paclitaxel in treating patients who have unresectable locally advanced or metastatic stomach cancer.

OBJECTIVES:

  • Determine the response rate in patients with unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction treated with bryostatin 1 and paclitaxel.
  • Determine the qualitative and quantitative toxicity and reversibility of toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and bryostatin 1 IV over 1 hour on days 2, 9, and 16. Treatment continues every 4 weeks for at least 2 courses in the absence of disease progression or unacceptable toxicity. Patients with a complete response (CR) receive up to 4 more courses after achieving CR.

Patients are followed until death.

PROJECTED ACCRUAL: A total of 18-35 patients will be accrued for this study.

Phase II
Interventional
Treatment
  • Esophageal Cancer
  • Gastric Cancer
Drug: paclitaxel
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Active, not recruiting
 
 
 

DISEASE CHARACTERISTICS:

  • Histologically confirmed unresectable locally advanced or metastatic adenocarcinoma of the stomach or gastroesophageal junction
  • Measurable disease

    • At least 20 mm with conventional techniques OR
    • At least 10 mm with spiral CT scan
    • The following are not considered measurable:

      • Bone lesions
      • Leptomeningeal disease
      • Ascites
      • Pleural/pericardial effusion
      • Inflammatory breast disease
      • Lymphangitis cutis/pulmonis
      • Abdominal masses that are not confirmed or followed by imaging techniques
      • Cystic lesions
  • No bone metastases as sole disease site
  • No brain metastases

PATIENT CHARACTERISTICS:

Age:

  • 18 and over

Performance status:

  • Zubrod 0-1
  • Karnofsky 60-100%

Life expectancy:

  • At least 12 weeks

Hematopoietic:

  • Granulocyte count at least 1,500/mm^3
  • Hemoglobin at least 8 g/dL
  • Platelet count at least 100,000/mm^3
  • No bleeding diathesis

Hepatic:

  • Bilirubin no greater than 1.5 mg/dL
  • Transaminases no greater than 2.5 times upper limit of normal

Renal:

  • Creatinine no greater than 1.5 mg/dL
  • Calcium no greater than 12 mg/dL
  • No symptomatic hypercalcemia

Cardiovascular:

  • No New York Heart Association class III or IV heart disease
  • No angina, myocardial infarction, or congestive heart failure in past 6 months

Other:

  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No serious concurrent infections, nonmalignant medical illnesses, or psychiatric disorders that may preclude study
  • No other prior malignancy in past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • At least 6 months since prior adjuvant immunotherapy
  • No prior immunotherapy outside of the adjuvant setting
  • No concurrent immunotherapy

Chemotherapy:

  • At least 6 months since prior adjuvant chemotherapy
  • No prior chemotherapy outside of the adjuvant setting
  • No other concurrent chemotherapy

Endocrine therapy:

  • Not specified

Radiotherapy:

  • At least 4 weeks since prior radiotherapy
  • No prior radiotherapy to major bone marrow containing areas (pelvis, lumbar spine) or to study lesion
  • No concurrent radiotherapy

Surgery:

  • At least 1 week since prior minor surgery (3 weeks for major surgery) and recovered

Other:

  • No concurrent anticoagulants
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006081
 
CDR0000068069, MDA-ID-99203, NCI-T99-0103
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Jaffer A. Ajani, MD M.D. Anderson Cancer Center
National Cancer Institute (NCI)
February 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP